M'ATH STD

K040686 · Intelligence IN Medical Technologies · LLZ · Jul 30, 2004 · Radiology

Device Facts

• Record ID: K040686
• Device Name: M'ATH STD
• Applicant: Intelligence IN Medical Technologies
• Product Code: LLZ · Radiology
• Decision Date: Jul 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

M'Ath® software is a Windows based application program running on a personal computer that is intended to aid the physician in the organisation of patient data relating to the ultrasound images or video acquired during vascular examination by sonography, and including patient characteristics. Additionally the software allows making measurements to determine the intima media thickness of the carotid artery from the accurate image and store them with the patient file.

Device Story

M'Ath® Std is PC-based software running on Windows; processes ultrasound images/video (AVI, JPEG, GIF, TIFF, BMP, PCX, PCD, TGA, EPS, IMG) captured from external ultrasound devices. Physician-operated in clinical settings; user identifies regions of interest for semi-automatic detection of carotid artery intima-media thickness (IMT). Software utilizes proprietary edge detection algorithms to calculate IMT and provides a quality index for measurements. Output includes stored patient measurements and reports; assists physicians in clinical decision-making regarding early atherosclerosis detection in the carotid vascular bed.

Clinical Evidence

No clinical trials required for substantial equivalence. Submission notes that some clinical data publications are included, but provides no specific study details, sample sizes, or performance metrics.

Technological Characteristics

PC-based software; Windows OS; keyboard/mouse interface. Supports multiple image formats (AVI, JPEG, GIF, TIFF, BMP, PCX, PCD, TGA, EPS, IMG). Features semi-automatic edge detection and IMT measurement with a proprietary quality index. Standalone deployment.

Indications for Use

Indicated for physicians to organize patient data and ultrasound images/video from vascular and echo-cardiology examinations of the cardiovascular system; used to measure carotid artery intima-media thickness (IMT) to aid in early atherosclerosis detection.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Q Lab Software (K021966)
• Sonocalc (K030223)

Submission Summary (Full Text)

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KOUOSLO

JUL 30 2004

Intelligence in medical Technologies 510K Pr

# 510K Summary of Safety and Effectiveness

(Completed on July 2004)

This summary of safety and effectiveness is provide in accordance with 21 CFR 807.92

#### 1. Submitter's Name

Intelligence in Medical Technologies 18-24 Rue Tiphaine Paris 75015 France + 33 (0)1 45 78 11 66 Contact person : Scott Pease PO Box 222 Hartland WI 53029 Tel :[phone] Fax : [phone]

Summary's Date preparation: Submitted March 1, 2004 (completed July 7th 2004)

2. Device trade name: M'Ath® Std

Common name: Ultrasound Medical Image Measurement Software

Classification Name: 892.2050-System, Image processing, Radiological.

## 3. Predicate substantially equivalent devices:

- K021966, Q Lab Software, Advanced Technology Laboratories, Inc. (dba Philips Ultrasound); -
- K030223, Sonocalc, SonoMetric Health, LLC.

4. Device description : M'Ath®Std is a software running on a stand alone computer under Microsoft Windows operating system. Images are captured from any ultrasound device. Proprietary algorithms are used to measure Intima Media Thickness ( IMT).Storage of patient measurements values can be performed during the examination. These measurements help to detect early atherosclerosis in the carotid vascular bed. Predicate device specifications comparison

| | PRINCIPAL DEVICE | PREDICATE DEVICE 1 | PREDICATE DEVICE 2 |
|---------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| | Intelligence in Medical<br>Technologies (IMT) | Advanced Technology<br>Laboratories (ATL) | SonoMetric Health ,LLC |
| | M'Ath Std | Q Lab Software<br>(K021966) | Sonocalc (K030223) |
| Computer<br>/Operating System | PC Based Hardware and<br>Microsoft Windows<br>operating system. | PC Based Hardware and<br>Microsoft Windows<br>operating system. | PC Based Hardware and<br>Microsoft Windows<br>operating system. |
| User Interface | PC Keyboard mouse ( 2<br>buttons) | PC Keyboard Mouse | PC Keyboard Mouse |
| Image Source | Ultrasound | Ultrasound | Ultrasound |
| Image Format | AVI, JPEG, GIF, TIFF,<br>BMP, PCX, PCD, TGA,<br>EPS, IMG. | AVI,BMP | JPEG and BMP |
| Data Storage<br>(image and Video) | Yes | Yes | Yes |
| Report Generation | Yes | Yes | Yes |
| Measurement of<br>Intima Media<br>Thickness | Yes | Yes | Yes |
| Semi Automatic<br>Detection (User<br>points out where to<br>detect) | Yes | Yes | Yes |
| Edge Detection | Yes | Yes | Yes |
| Quality Index | Yes | No | Unknown |

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#### 5.Intended use

M'Ath® software is a Windows based application program running on a personal computer that is intended to aid the physician in the organisation of patient data relating to the ultrasound images or video acquired during vascular examination by sonography, and including patient characteristics. Additionally the software allows making measurements to determine the intima media thickness of the carotid artery from the accurate image and store them with the patient file.

Performance data: There are no section 514 performance standards for this class of device for assisting in the determination of its substantial equivalence.

## Conclusions drawn from clinical and non clinical test data:

Not required for determination of substantial equivalence for this class of device, though publication of some clinical data are contained in this premarket submission.

Substantial equivalence summary: The Intelligence in Medical Technologies (IMT), M'Ath Software is comparable and substantially equivalent to a legally marketed predicate device. The intended use of the Intelligence in Medical Technologies (IMT) software is the same as that of the of the predicate devices "Q Lab Software" marketed by Advanced Technologies Laboratories (d.b.a Philips Ultrasound) and "Sonocalo" marketed by Sonometrics Health ,LLC" . No new safety or effectiveness issues are raised with M'Ath™ Std.The subject device has substantially equivalent technological characteristics, features, specifications, mode of operation, and intended use as a legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem consisting of three curved lines that resemble a bird in flight. The emblem is positioned in the center of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 3 0 2004

Intelligence in Medical Technologies % Mr. Scott J. Pease, ASQ CQA-HACCP Consultant, Regulatory/QS PEASE Consulting P.O. Box 222 HARTLAND WI 53029

Re: K040686 Trade/Device Name: M'Ath® Std Regulatory Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 12, 2004

Received: July 19, 2004

Dear Mr. Pease:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bugden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| er/ 3 - 4/24/96 | |
|---------------------------|--------------------------------------|
| Applicant: | Intelligence in Medical Technologies |
| 510(k) Number (if known): | K040686 |
| Device Name: | M'Ath Std Software |

Indications For Use: M'Ath Std software is a Windows-based application program running on a personal
computer that is intended to aid the physician in the organization of patient data relating to the
ultrasound images or video acquired during echo-cardiology exams of the cardiovascular system,
including the patient's characteristics. Additionally, the software allows the physician to makes
measurements to determine the intima-media thickness of the carotoid artery from the acquired images
and stores them with the patient file.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

| Prescription Use | |
|------------------|--|
|------------------|--|

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

| 510(k) Number | K040686 |
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|---------------|---------|

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